CONVINCE - Protocol v 3.0 12 August 2020
Research type
Research Study
Full title
CONVINCE - COLchicine for preventioN of Vascular Inflammation in Non-CardioEmbolic stroke) - a randomised clinical trial of low-dose colchicine for secondary prevention after stroke.
IRAS ID
215780
Contact name
Christopher Price
Contact email
Sponsor organisation
University College Dublin
Eudract number
2015-004505-16
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 4 months, 30 days
Research summary
CONVINCE-A randomised clinical trial of low dose colchicine for secondary prevention after stroke
Patients who have recently had a stroke or transient ischemic attack may be invited to take part in the CONVINCE Study.
To reduce the risk of another stroke, the standard care often includes medicine that slows clotting (e.g aspirin), reduces cholesterol (e.g statins), and lowers blood pressure. The purpose of this study is to compare an anti-inflammatory medication called colchicine used with standard treatment to standard treatment is no placebo medication
This is a research study because colchicine has not yet been proven to prevent stroke/heart attack after stroke. It is expected that about 2623 patients from at least 5 countries will participate.
The study medicine is colchicine. It works by blocking the action of proteins (tubilins) that play important roles in inflammation. Inflammation increases the risk of stroke and heart attack.
At low doses similar to the dose in this study, colchicine has been safely used for many years in the treatment of joint diseases, such as gout and Familial Mediterranean Fever. It is taken by mouth, once a day with a glass of water. The dose in the study is 0.5 mg (one tablet per day)
Participants will be followed for 12-60 months.
Participants will be asked to attend clinic visits at 1 month and every 6 months until the end of the study. At each visit study staff will:
If assigned to colchicine, check that the participant is taking it and other medicines.
Collect information about any new medical problems , or possible side effects from medicines.
Provide the participant with a new supply of colchicine, if they are assigned to it.
Check heart rate, blood pressure and level of independence.A blood test will be taken at the first visit and once per year thereafter.
This research is funded by the Health Research Board of Ireland.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
17/NE/0061
Date of REC Opinion
12 Apr 2017
REC opinion
Further Information Favourable Opinion